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Radioimmunotherapy

Peripheral Blood Stem Cell Transplantation for Acute Lymphoblastic Leukemia

Q: How is Cyclosporine most often used to help patients?

<p>Cyclosporine is often used to treat <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a>, non-hodgkin. Other potential benefits of taking cyclosporine include prevention of stem cell <a href="https://www.withpower.com/clinical-trials/transplant">transplant</a> rejection, <a href="https://www.withpower.com/clinical-trials/interstitial-cystitis">interstitial cystitis</a> treatment, and managing nephrotic syndrome.</p>

Phase 1 & 2

Waitlist Available

Led By Brenda M. Sandmaier

Research Sponsored by Fred Hutchinson Cancer Research Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial gives cancer patients astatine-211, a radioactive substance, before their donor stem cell transplant. The hope is that the astatine will kill the cancer cells while having less of an effect on the healthy cells.

Eligible Conditions

Acute Lymphoblastic Leukemia
Acute Leukemia
Acute Myeloid Leukemia
Chronic Myelomonocytic Leukemia
Myelodysplastic Syndrome
Acute Myelogenous Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of patients who develop grades III/IV Bearman regimen-related toxicity

Secondary outcome measures

Achievement of remission

Disease-free survival

Duration of remission

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (211^At-BC8-B10, PBSC)Experimental Treatment8 Interventions

Patients receive 211^At-BC8-B10 IV over 6-8 hours on day -7 and fludarabine phosphate IV over 30 minutes on days -4, -3 and -2. Patients undergo TBI and PBSC transplant on day 0. Patients also receive cyclosporine PO or IV every 12 hours on days -3 to 56 and then tapered to day 180, or continuing to day 96 and then tapered to day 150. Patients receive mycophenolate mofetil PO or IV (first dose to occur 4-6 hours after PBSC infusion) every 12 hours on days 0-27 (for patients with related donors) or every 8 hours on day 0 and then reduced to every 12 hours on days 30-150 then tapered to day 180 (for patients with unrelated donors).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Peripheral Blood Stem Cell Transplantation

1997

Completed Phase 3

~1330

Mycophenolate Mofetil

1997

Completed Phase 4

~2380

Total-Body Irradiation

1997

Completed Phase 3

~1180

Pretargeted Radioimmunotherapy

2010

Completed Phase 1

~20

Cyclosporine

1997

Completed Phase 3

~1830

Fludarabine Phosphate

1997

Completed Phase 3

~2390

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor

443 Previous Clinical Trials

148,260 Total Patients Enrolled

Fred Hutchinson Cancer CenterLead Sponsor

557 Previous Clinical Trials

1,343,403 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,703 Previous Clinical Trials

40,931,775 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other scientific papers which have researched Cyclosporine?

"At this time, 599 clinical trials are underway that focus on cyclosporine. Of these, 58 are in phase 3. Many of the trials for cyclosporine are based in Philadelphia, Pennsylvania; however, there are 5940 locations running studies for this treatment across the globe."

Answered by AI

Is this research project only testing people who are under 40 years old?

"The age requirements to participate in this study are between 18-75 years old."

Answered by AI

How can I enroll in this research project?

"Eligibility requirements for this leukemia clinical trial include being between 18 and 75 years old. Myelomonocytic and chronic subtypes of the cancer are also admissible. A total of 50 patients are needed for recruitment."

Answered by AI

Are investigators still looking for study participants?

"This study, which was originally posted on October 24th 2017, is still actively recruiting participants according to information found on clinicaltrials.gov. The listing was last updated on August 29th 2022."

Answered by AI

How is Cyclosporine most often used to help patients?

"Cyclosporine is often used to treat lymphoma, non-hodgkin. Other potential benefits of taking cyclosporine include prevention of stem cell transplant rejection, interstitial cystitis treatment, and managing nephrotic syndrome."

Answered by AI

Recent research and studies

Plos OneJournal

Cgmp Production of Astatine-211-labeled Anti-cd45 Antibodies for Use in Allogeneic Hematopoietic Cell Transplantation for Treatment of Advanced Hematopoietic Malignancies

Li, Yawen, Donald K. Hamlin, Ming-Kuan Chyan, Roger Wong, Eric F. Dorman, Robert C. Emery, Douglas R. Woodle, et al.. 2018. “Cgmp Production of Astatine-211-labeled Anti-cd45 Antibodies for Use in Allogeneic Hematopoietic Cell Transplantation for Treatment of Advanced Hematopoietic Malignancies”. Edited by Michael Ernst-Heinrich Fassbender. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0205135.

clinicaltrials.govStudy

211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia

2017. "211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03128034.